Ewing's sarcoma
Conditions
Interventions
200 metastatic patients diagnosed with Ewing's sarcoma will receive alternating cycles of VDC (Vincristine, Doxorubicin and Cyclophosphamide) and IE (Ifosfamide and Etoposide) - completing 14 cycles i
we consider it important that in these patients, surgery be done as soon as possible after radiotherapy (it is not prudent to delay surgery)
Patients with dry pelvic tumors resected with free margins
Q65.070
Sponsors
Hospital de Clínicas de Porto Alegre
Instituto do Câncer Infantil
Rafael Koff Acordi
Eligibility
Age
No minimum to 40 Years
Inclusion criteria
Inclusion criteria: Diagnosis of bone or soft tissue Ewing sarcoma; or extracellular PNET bone or soft tissue; who did not receive prior chemotherapy or radiation therapy;up to forty years; Informed Consent Form (TCLE) signed by the patient or his / her legal guardian;Number of participants in Brazil: 100
Exclusion criteria
Exclusion criteria: Unconfirmed diagnosis; Absence of metastases; Pregnancy and lactation; Patients with previous treatments for this disease; Patients participating in other studies using potentially therapeutic agents for this disease; Patients with metastatic Ewing's sarcoma as a second cancer, unless the first tumor was adequately treated squamous and basal cell skin carcinoma;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Describe the event-free survival of the protocol that is defined as time from diagnosis to disease recurrence / progression. This is a study without a control group, which will recruit 200 patients over a five year period and there will be later comparison with historical controls the survival will be studied through Kaplan-Meier curves, being the effect of the various prognostic factors evaluated in a multivariate model of proportional hazards regression (Cox model) The data will be processed and analyzed with the aid of the SPSS program (Statistical Package for the Social Sciences) and Epi Info | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival It will be calculated from the time of diagnosis of the disease and the event of death of the patient. Patients with loss of follow up will be censored on the date of the last consultation. Descriptive analyzes will be presented Quantitative data will be described by mean +/- standard deviation. In case of asymmetry will be used the median and the interquartile range (P25 to P75) 44 also accompanied by the minimum and maximum values. Categorical variables will be described with proportions Bivariate comparisons will have their significance determined by chi-square tests or Student's t-test, according to the type of data involved;Incidence of general protocol toxicity (induction chemotherapy, consolidation and maintenance); The toxicity will be calculated according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Descriptive statistics on the occurrence of events will also involve the use of of the incidence density with their respective confidence intervals of 95% In addition, the survival will be studied through Kaplan-Meier curves, being the effect of the various prognostic factors evaluated in a multivariate model of proportional hazards regression (Cox model) The data will be processed and analyzed with the aid of the SPSS program (Statistical Package for the Social Sciences) and Epi Info | — |
Countries
Argentina, Brazil, Chile, Uruguay
Contacts
Public ContactLauro;André Gregianin;Brunetto
Hospital de Clínicas de Porto Alegre;Instituto do Câncer Infantil
Outcome results
None listed